Cancer Survivor Clinical Trial
Official title:
Adaptation and Pilot-Testing a Parenting Intervention for Spanish-Speaking Parents of Children at Risk for Neurocognitive Late Effects
Verified date | August 2021 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot clinical trial studies a culturally adapted skills training and educational intervention in guiding parents of younger acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) survivors at risk for long-term attention and memory problems (late neurocognitive effects). ALL and AML treatments target the central nervous system and may put younger survivors at increased risk for late neurocognitive effects, which may lead to learning difficulties or behavior problems and poor health-related quality of life. Spanish-speaking parents of young ALL or AML survivors may not have access to the information, resources, or guidance to help their children through these difficulties. Adapting an existing parent-training program into Spanish may help teach Spanish-speaking parents effective ways to prevent or reduce learning and behavioral difficulties, which may improve the quality of life of parents and young ALL or AML survivors.
Status | Completed |
Enrollment | 38 |
Est. completion date | April 18, 2016 |
Est. primary completion date | April 18, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: INCLUSION CRITERIA FOR FOCUS GROUPS (PHASE I) - Parents or adult primary caregiver (e.g., grandmother) of children ages 5 to 17 in treatment remission and has completed intensive therapy for ALL or AML - Parents of childhood cancer survivors who are now 18 years or older and who were previously treated for ALL or AML (do not need to live with the child) - One or both of the parents will self-identify as Hispanic/Latino, the primary participating parent will be either Spanish speaking, bilingual, or is bilingual but identifies their primary language as English and will live with the child INCLUSION CRITERIA FOR PILOT-TESTING (PHASE II) - Parent/Caregiver: parents or adult primary caregiver (e.g., grandmother) of children treated for ALL or AML - Parent/Caregiver: one or both of the parents will self-identify as Hispanic/Latino, the primary participating parent will be either Spanish speaking, bilingual, or is bilingual but identifies their primary language as English and will live with the child - Child: child is in treatment remission and has completed intensive therapy - Child: child is age 5 to 17 years, 11 months - Child: child understands English Exclusion Criteria: EXCLUSION CRITERIA FOR FOCUS GROUPS (PHASE I) - Parents of ALL or AML survivors with a history of a major psychiatric condition that precludes participation (e.g., psychosis, severe depression, active substance abuse) - Existing history of severe cognitive impairment in the child as reported by the parents or documented in the child's City of Hope medical records EXCLUSION CRITERIA FOR PILOT TESTING (PHASE II) - Parent/Caregiver: parents with a history of a major psychiatric condition that precludes participation (e.g., psychosis, severe depression, active substance abuse) - Child: survivors with a history of a major psychiatric condition that precludes participation (e.g., psychosis, severe depression, active substance abuse) - Child: existing history of severe cognitive impairment (intelligence quotient [IQ] =< 70) as reported by the parents or the child's City of Hope medical records, or by the child's performance score on the Wechsler Intelligence Scale for Children (WISC) Working Memory and Processing Speed index measures administered in this study |
Country | Name | City | State |
---|---|---|---|
United States | City of Hope Medical Center | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility, measured by the percentage of parents who complete the entire adapted skills-training parenting intervention | Feasibility will be operationally defined as > 75% of parents completing the intervention. | After 6 sessions (up to 12 months) | |
Secondary | Change in child's school-related health-related quality of life (HRQOL) score as assessed by the Pediatric Quality of Life scale | Explored for pre- and post-intervention changes using descriptive analyses. | Baseline to up to 12 months | |
Secondary | Change in learning strategies as measured by the School Motivation and Learning Strategies Inventory | Explored for pre- and post-intervention changes using descriptive analyses. | Baseline to up to 12 months | |
Secondary | Change in parent knowledge and efficacy, as measured by the Parent Knowledge, Beliefs, and Behaviors Questionnaire (PBQ) | Explored for pre- and post-intervention changes using descriptive analyses. | Baseline to up to 12 months | |
Secondary | Parent satisfaction with the intervention as measured by the perceived benefits scale | Satisfaction with intervention is defined as group mean rating of > 3/5 on the perceived benefit scale. Perceived benefit will be examined using group means obtained from parents' ratings on satisfaction and barriers questionnaires. | Up to 12 months |
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